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The anti-HBs produced after hepatitis B vaccination will decrease over time. College students are vaccinated with hepatitis B vaccine at birth, and their antibodies may have decreased significantly. In addition, college students are sexually active population, which has a high risk of HBV infection. It is necessary to study the anti-HBs level of college students, and analyze the strengthening immunization for this special group.
This study will analyze the immunogenicity, immune persistence, and safety of booster dose of intramuscular 20 µg recombinant hepatitis B vaccines. Different booster vaccination including one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) was given according to the antibody production level after booster vaccination among college students.
Participants are given booster dose of one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) 20 µg recombinant hepatitis B vaccine according to the antibody production level. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 µg at month 0, months 0, 1 or 0, 1, and 6 | Experimental | 20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 0, 1, and 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 µg dose hepatitis B vaccine | Biological | one-dose, two-dose or three-dose, 20 µg per dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs Seroconversion Rate at Months 1 | Anti-HBs Seroconversion Rate at Months 1 | Months 1 |
| Anti-HBs Seroconversion Rate at Months 3 | Anti-HBs Seroconversion Rate at Months 3 | Months 3 |
| Anti-HBs Seroconversion Rate at Months 7 | Anti-HBs Seroconversion Rate at Months 7 | Months 7 |
| Anti-HBs Seroconversion Rate at Months 12 | Anti-HBs Seroconversion Rate at Months 12 | Months 12 |
| Anti-HBs Seroconversion Rate at Months 18 | Anti-HBs Seroconversion Rate at Months 18 | Months 18 |
| Anti-HBs Seroconversion Rate at Months 24 | Anti-HBs Seroconversion Rate at Months 24 | Months 24 |
| Anti-HBs Seroconversion Rate at Months 30 | Anti-HBs Seroconversion Rate at Months 30 | Months 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs Concentration at Months 1 | Anti-HBs Concentration at Months 1 | Months 1 |
| Anti-HBs Concentration at Months 3 | Anti-HBs Concentration at Months 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events After Vaccination | Occurrence of Adverse Events After Vaccination | Within 7 days after the vaccination |
| Occurrence of Adverse Events After Vaccination | Occurrence of Adverse Events After Vaccination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suping Wang, PhD | Contact | +86-351-4135103 | supingwang@sxmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Suping Wang, PhD | Shanxi Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| Months 3 |
| Anti-HBs Concentration at Months 7 | Anti-HBs Concentration at Months 7 | Months 7 |
| Anti-HBs Concentration at Months 12 | Anti-HBs Concentration at Months 12 | Months 12 |
| Anti-HBs Concentration at Months 18 | Anti-HBs Concentration at Months 18 | Months 18 |
| Anti-HBs Concentration at Months 24 | Anti-HBs Concentration at Months 24 | Months 24 |
| Anti-HBs Concentration at Months 30 | Anti-HBs Concentration at Months 30 | Months 30 |
| Within 28 days after vaccination |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |